Moderna, Baxter in Mfg Pact for COVID Vaccine; Supply Updates in AsiaBy
Moderna and Baxter BioPharma Solutions have entered into an agreement for Baxter to provide fill–finish sterile manufacturing and supply packaging for approximately 60 million to 90 million doses of the Moderna’s COVID-19 vaccine in 2021. Moderna is also working with Takeda Pharmaceutical and the Philippine government for the distribution of Moderna’s COVID-19 vaccine in Japan and the Philippines, respectively. Also, the company is evaluating booster shots against COVID-19 variants.
The manufacturing of the Moderna’s COVID-19 vaccine will take place at Baxter’s fill–finish sterile manufacturing facilities in Bloomington, Indiana. The site has capabilities in parenteral delivery systems and clinical and commercial vaccine manufacturing for vaccines and parenteral drugs.
Supply updates in Japan and the Philippines
Takeda has submitted a new drug application to Japan’s Ministry of Health, Labour and Welfare to import and distribute Moderna’s COVID-19 vaccine candidate (mRNA-1273 or TAK-919) in Japan. TAK-919 is Takeda’s development name for Moderna’s COVID-19 vaccine candidate.
Takeda is conducting a Phase I/II study in Japan to evaluate the safety and immunogenicity of two doses at the 100-μg dose level given 28 days apart in 200 participants aged 20 years and above. Takeda completed enrollment of this Phase I/II study last month (February 2021). Once available, the Phase I/II study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency.
Takeda and Moderna previousl announced that Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021, pending licensure in Japan.
Moderna has also announced a supply agreement with the Philippine government for 13 million doses of its COVID-19 vaccine. Under the agreement, deliveries would begin in mid-2021. Moderna’s COVID-19 vaccine is not currently approved for use in the Philippines, and the company says it will work with regulators to pursue necessary approvals prior to distribution. A separate agreement with the Philippine government and private sector for the supply of an additional 7 million doses is also anticipated.
Evaluating COVID-19 booster vaccine
Moderna has dosed the first participants with its modified COVID-19 vaccines, designed to address the potential need for booster vaccine candidates against COVID-19 variants in a Phase II clinical study.
Previously published data has shown that vaccination with the Moderna’s COVID-19 vaccine produced neutralizing titers against all key variants tested, including B.1.1.7, first identified in the UK, and B.1.351, first identified in the Republic of South Africa, with a six-fold reduction in neutralizing titers against B.1.351. “Out of an abundance of caution,” Moderna says it is pursuing a clinical development strategy against these emerging variants.
Phase II study participants vaccinated with the vaccine have been offered a single 50-µg booster dose. In parallel, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase I clinical trial to assess the monovalent and multivalent modified vaccines as a primary series in naïve individuals and as a booster vaccine in those previously vaccinated with Moderna’s vaccine. NIAID will initiate this study after receiving safe-to-proceed authorization from the US Food and Drug Administration.